三层共挤输液用膜、袋质量标准的起草说明英文版

聚丙烯/聚丙烯/聚丙烯三层共挤输液用膜、袋质量标准的起草说明
一．概况为了有效地加强对药包材质量的控制，便于生产企业的使用。

聚丙烯/聚丙烯/聚丙烯三层共挤输液用膜、袋质量标准中项目及指标的设立是在参考药包材国家标准多层共挤输液用膜、袋通则（YBB00342002）、日本药局方（14版）及塑料输液容器（ISO 15747 ：2003）的相关内容的基础上，按中国药典编写格式进行起草的。

二．关于标准项目设立及要求的说明1．名称根据一个品种一个名称的原则，本标准的名称拟定为聚丙烯/聚丙烯/聚丙烯三层共挤输液用膜、袋。

2．外观采用多层共挤输液用膜、袋通则（YBB00342002）中外观项下的规定。

3．鉴别为了有效的控制产品质量，加强对配方的监控，设置鉴别试验很有必要。

选择的方法皆具有专属性强、重现性好、灵敏度高、操作简便、快速等的特点。

与多层共挤输液用膜、袋通则（YBB00342002）相比，增加了观察材料层数的物理构成项目。

（1）显微特征与通则相比，增加了显微特征这一项目，采用显微镜观察法，可快速、简便的对材料的层数进行定性鉴别。

（2）红外光谱采用多层共挤输液用膜、袋通则（YBB00342002）中红外光谱项下的规定，方法采用包装材料红外光谱测定法（YBB00262004）第五法。

4．灭菌适应性试验、使用适应性试验均采用多层共挤输液用膜、袋通则（YBB00342002）中灭菌适应性试验、使用适应性试验项下的规定，经实验验证，产品基本符合规定。

5．物理性能（1）水蒸气渗透（膜）设置本试验的目的是考察膜材对水蒸气的阻隔能力，试验方法采用水蒸气透过量测定法（YBB00092003）中的第一法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

（2）水蒸气渗透（袋）试验方法采用水蒸气透过量测定法（YBB00092003）中的第一法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

（3）氧气透过量（膜）设置本试验的目的是考察膜材对氧气的阻隔能力，试验方法采用气体透过量测定法（YBB00082003）中的第一法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

（4）氮气透过量（膜）设置本试验的目的是考察膜材对氮气的阻隔能力，试验方法采用气体透过量测定法（YBB00082003）中的第一法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

（5）拉伸强度（膜）设置本试验的目的是考察膜材的物理机械强度，由于多层共挤膜属于软质的、机械强度较大的材料，根据拉伸性能测定法（YBB00112003）中规定的速度选择原则，即软质塑料选择较高的试验速度，因此在本标准中对拉伸速度做了调整。

指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

（6）热合强度（袋）设置本试验的目的是考察成品输液袋各封边的牢固度，试验方法采用热合强度测定法（YBB00122003）中复合袋的测定方法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中的规定。

7．透光率试验方法和指标均采用多层共挤输液用膜、袋通则（YBB00342002）中透光率项下的规定。

8．炽灼残渣主要控制粒料中各添加剂的无机总量，方法经试验验证采用了塑料输液容器（ISO 15747：2003）及聚丙烯输液瓶（YBB00022002）中炽灼残渣项下的方法，即在试验过程中不加硫酸直接在550℃的条件下灼烧。

这样既便于可利用炽灼残渣项下的残渣进行金属元素试验，同时也可避免材料在空气中灼烧时易发生的自燃现象。

指标设置仍采用多层共挤输液用膜、袋通则（YBB00342002）中炽灼残渣项下的规定。

9．金属元素主要为了控制粒料聚合中催化剂及生产管道等设备中中混入的金属元素，需对有毒、有害金属进行针对性检查。

试验方法和指标均采用多层共挤输液用膜、袋通则（YBB00342002）中金属元素项下的规定。

10．溶出物试验进行本试验的目的是为了控制输液膜材料中的某些物质被水溶出，模拟输液的使用情况，监控溶出物的量，以确保药液的安全、有效。

除增加了泡沫试验一项以外，其它项目的试验方法和指标均采用多层共挤输液用膜、袋通则（YBB00342002）中溶出物试验项下的规定。

经实验验证，产品基本符合规定。

（1）泡沫试验为控制材料中的表面活性剂成分，特设此项目，方法采用了日本药局方（14版）中对输液容器规定的检查方法。

9.细菌内毒素指标和方法
均采用多层共挤输液用膜、袋通则（YBB00342002）中内毒素项下的规定。

10．生物性能（1）细胞毒性输液产品是一种安全性要求极高的品种，从安全的角度出发，我们在标准中设置了生物学评价中首选的体外筛选试验——细胞毒性试验。

试验方法采用，指标采用细胞毒性检查法（YBB00012003）中的第一法，指标采用多层共挤输液用膜、袋通则（YBB00342002）中细胞毒性项下的规定。

（2）致敏试验、皮内刺激、急性全身毒性和溶血试验鉴于该包材的使用与人体的安全和健康密切相关，故在本标准中设置了生物安全线评价试验：致敏试验、皮内刺激、急性全身毒性和溶血试验。

致敏试验方法采用皮肤致敏检查法（YBB00052003），皮内刺激试验方法采用皮内刺激检查法（YBB00062003），急性全身毒性采用急性全身毒性检查法（YBB00042003），溶血试验方法采用溶血检查法（YBB00032003），指标均采用多层共挤输液用膜、袋通则（YBB00342002）中生物试验项下的规定。

typeⅰ
2.5 s-2 抗跌of special examination level s-4 2.5 special examination level s-4 2.5 in special examination level s-1 1.5 special examination level s-2 2.5 special examination level s-2 2.5 special examination level s-2 2.5 special examination level 2.5 s-2 (bags) special examination level s-1/polypropyrene/1.5th
polypropyrene costringency polypropyrene three-tier IV film and bag of quality standards for drafting instructions 1. General situation in order to effectively strengthen the quality control of drug packaging materials, the use of easy-to-production enterprise. Polypropyrene/polypropyrene/costringency polypropyrene three-tier IV film and bag items in quality standards and indicators is the national standard reference to drug packaging coextrusion Infusion bags with film, lawk (YBB00342002), Japan pharmacy party (14) and plastic infusion containers (ISO 15747: 2003) on the basis of relevant content, according to the Chinese Pharmacopoeia for the drafting of written format. 2. the establishment of a standard project and a description of the request (1) the name under a variety of the principle of a name, the name of this
standard as polypropyrene/quasi-definite polypropyrene/costringency polypropyrene three-tier IV film and bag. 2. the appearance of the polybromide layer co-squeezed IV, bag General Clauses (YBB00342002) under the skin. 3. identification for effective control of product quality, strethening despensing monifored, set up test is necessary. Both have chosen specialization, reproducibility, sensitive, easy, fast, and so on. And multilayer coextrusion Infusion bags with film, lawk (YBB00342002), increasing the observation of the physical material layers that make up the project. (1) compared to the microscopic characteristics and lawk, an increase of microscopic characteristics of this project, using a microscope, quick and easy on the number of levels for identification. (2)-IR polybromide extruded IV film or sack General Clauses (YBB00342002) in the infrared spectrum, takes the packaging material IR method (YBB00262004). 4. sterilizaion adaptability, using adaptive test this using coextrusion IV film and bag General Clauses (antispesis YBB00342002), adaptability in use under the adaptability of the basic experimemental, product compliance. 5. perfornamce (1) water vapour permeability (film) the purpose of this experiment is to study membrane on steam signalbehind ability to test method takes measurements nonfilm (YBB00092003) in the first method, the index polybromide extruded film and bag IV (YBB00342002) in lawk. (2) water vapour permeability (bag) test method takes measurements nonfilm (YBB00092003) in the first method, the index polybromide extruded film and bag IV (YBB00342002) in lawk. (3) the amount of oxygen through (film) the purpose of this experiment is to study membrane on oxygen signalbehind ability, gas permeation test method takes measurements (YBB00082003) in the first method, the index polybromide extruded film and bag IV (YBB00342002) in lawk. (4) the amount of nitrogen through (film) the purpose of this experiment is to study membrane on the preparationg signalbehind ability, gas permeation test method takes measurements (YBB00082003) in the first method, the index polybromide extruded film and bag IV (YBB00342002) in lawk. (5) tensile strength (film) the purpose of this test is the study of the physical and mechanical strength by lecithin, due to the film coextrusion belong to the soft, mechanical strength of the larger materials, according to the determination of tensile properties (YBB00112003) speed option, that is, soft plastic select higher test, so in this international standard speed to do in the drawing. Index polybromide extruded film and bag IV (YBB00342002) in lawk. (6) rahfu strength (bags) the purpose of this test is to review the product Infusion bags to test out the firmness of edge banding method takes an rahfu method for determination of strength (YBB00122003) compaund method for determination of bags, index polybromide extruded film and bag IV (YBB00342002) in lawk. 7. the transmittance of test methods and indicators have adopted the coextrusion IV film and bag General Clauses (YBB00342002) under the transmittance. 8. the main control rasidues amustion Alex aggregatesbased additives'sulfur-inorgano in all, the total amount of experimental verification of identification with the plastic infusion containers (ISO 15747: 2003) and YBB00022002 polypropyrene infusion bottles (amustion rasidues), not a means of the method, which is a test in sulfur directly in such conditions as the 550 ° c for ignition. This will not only facilitate can make use of Chi-amustion rasidues to the rasidues test, as well as metallic elements to avoid burning material in the air of spontaneous when trre. Target is still being adopted coextrusion IV film and bag General Clauses (YBB00342002) amustion rasidues in believing that it is not a means. 9. the main metal elements to control the aggregatesbased polymerization catalysts and production pipeline equipment mixes dostrobiton, poisonous metals targeted checks. Test method and index follows the coextrusion Infusion bags with film, lawk (YBB00342002) under the heading of
dements. 10. eluates tests, the test is designed to help control infusion film materials some substances are dissolving, simulating usage, monitor and control the amount of dissolubility to ensure the safe and effective drug solution. In addition to the increase of a test, the test method for other projects and targets of this using coextrusion IV film and bag General Clauses (YBB00342002) in dissolubility under the heading of experiments. Via experimemental, product base is in order. (1) test for controlmaterial of surfactant components, the ad hoc group of this project, the method adopted in Japan pharmacy party (14 Edition on infusion containers of method.
9. the indicators and methods for bacterial endotoxins are made of multiple layers of co-squeezed IV film or sack General Clauses (YBB00342002) in that it is in lipopolysacharide. 10. biological properties (1) the cytotoxicity of infusion products is a security requirement, from a security point of view, we in standard biological evaluation are set in the preferred in vitro screening tests--cell toxicity. Test method takes, the indicator with cytotoxic inspection method (YBB00012003) in the first method, the index polybromide extruded film and bag IV (YBB00342002 lawk) under the cytotoxicity. (ii) sensitization for the test, intradermic stimulation, acute systemic toxicity and hemolysis test the use of the material and human safety and health are closely related, so in this international standard are set in the evaluation of bio-safety line: allergy to test, intradermic stimulation, acute systemic toxicity test and hemolysis. Sensitization for the test method takes maximization test (YBB00052003), intradermic challenge test method takes intradermic stimulation with (YBB00062003), acute systemic toxicity with acute systemic toxicity testing method (YBB00042003), lysophosphatidyl lysophosphatidyl test method takes an inspection method (YBB00032003), the indicator of this using coextrusion IV film and bag General Clauses (YBB00342002) under the biometic test.。